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a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis in Sjögren's Disease

Study acronym: cell-free RNA
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn whether salivary cell-free RNA (cfRNA) can be used as a non-invasive liquid biopsy test to help diagnose Sjögren's disease (SjD) and understand disease-related changes in the salivary glands. The main questions it aims to answer are: * Can salivary cfRNA distinguish patients with SjD from people with sicca symptoms who do not have SjD? * Are salivary cfRNA signals associated with clinical features of SjD, such as autoantibody-related immune activity and salivary gland pathology? * Can salivary cfRNA signals be linked to specific cell types and tissue regions in the salivary glands? Participants will provide saliva samples, and clinical information from routine medical evaluation will be collected. Some available salivary gland tissue transcriptomic data will also be analyzed to explore the possible tissue sources of salivary cfRNA signals.
Trial Details
NCT Number NCT07824440
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions Sjögren's Disease
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov